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K Number
K081705
Device Name
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
Manufacturer
LANG DENTAL MFG. CO., INC.
Date Cleared
2008-09-17

(92 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LANG DENTAL RESINCAP PATTERN AND COPING ACR YLIC RESIN is intended for the fabrication of patterns and copings.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a dental acrylic resin. It is a regulatory document and does not contain any information about acceptance criteria or a study proving device performance as requested. The letter confirms that the device, "Lang Dental Resincap Pattern and Coping Acrylic Resin," is substantially equivalent to legally marketed predicate devices for its intended use in "the fabrication of patterns and copings."

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies against acceptance criteria.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.